AIM

To determine the effectiveness of a home-based kidney care (HBKC) model of patient activation with lifestyle intervention compared with usual care (UC) in improving patient activation and to preliminarily evaluate its potential effect on markers of and risk factors for chronic kidney disease (CKD) in rural adult Zuni Indians with the disease.

METHODS

We screened 315 Zuni Indians who had ≥2 risk factors (family history of diabetes and kidney disease, microalbuminuria, overweight/obesity, and increased A) for CKD. We randomized 125 participants with CKD to a UC or an HBKC intervention (1:1) group. After initial lifestyle coaching, the intervention group also received reinforcement—about adherence to medications, diet, and exercise; self-monitoring; and coping strategies for living with stress—in the form of continuous engagement with community health representatives and in quarterly group sessions. The primary outcome was change at 12 months in Patient Activation Measure (PAM), which assesses an individual's knowledge, skill, and confidence in managing his or her own health and health care.

RESULTS

Of the 125 individuals randomized to the study (63 to the HBKC intervention and 62 to the UC control), 98 (49 in each treatment group) completed the 1-year study, and no individuals crossed over from 1 treatment group to the other. Among those who completed the study, we observed improvements in our primary outcome measure of PAM. The HBKC group increased its PAM total score by 8.6 points (95% CI, 1.2-16.0) more than those in the UC group ( = .023). Of those with valid 12-month PAM scores, 34 in the HBKC group and 39 in the UC group were in the PAM-activated group (PAM level >3) at baseline. At study completion, a significantly higher percentage of those from the HBKC group moved into the PAM activated group (12 of 14 [85.7%]) than into the UC group (2 of 9 [22.2%]), and a lower percentage of patients left the PAM-activated HBKC group during treatment (4 of 34 [11.8%]) than the UC group (8 of 39 [20.5%]; = .002). Of the 27 secondary outcomes, the HBKC group improved more than the UC group for body mass index (BMI), A, high-sensitivity C-reactive protein (hsCRP), and mental subscale of the SF-12 questionnaire. HBKC had no effect on medication or dietary adherence. In particular, we observed a decrease in BMI of 1.05 (95% CI, 0.3-1.8) more in the HBKC group than in the UC group ( = .007), a decrease in A levels of 0.92% (95% CI, 0.86-0.99) more in the HBKC compared with the UC group ( = .022), and a decrease in hsCRP levels by 5.6 mg/L (SD = 9.08) in the HBKC group compared with an increase of 5.7 mg/L (SD = 13.1) in the UC group ( < .001). The HBKC group increased its SF-12 mental subscale score by 3.5 points (95% CI, 0.4-6.7) more than the UC group ( = .028). There were no significant differences between the 2 groups in the SF-12 physical health, burden of kidney disease, effects of kidney disease, and symptoms and problems of Kidney Disease Quality of Life scales. The study did not find significant differences between the 2 groups in adherence to prescribed medications or dietary guidelines.

CONCLUSIONS

A HBKC intervention of continuous patient engagement improved participants' activation in their health and health care, as measured by the PAM instrument, and reduced markers of and risk factors for CKD. This randomized controlled trial proves that the HBKC intervention can have positive effects in patients with CKD among rural and disadvantaged populations.

LIMITATIONS

(1) The statistically significant difference in primary outcome had wide CIs, reflecting our small sample size; and (2) our study did not assess the contribution of the individual components of the HBKC intervention program to improved activation.